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Rybelsus, the first oral GLP-1 receptor agonist for type 2 diabetes, is manufactured by Novo Nordisk, a Danish pharmaceutical company with over 100 years of expertise in diabetes care. This innovative medication contains semaglutide, the same active ingredient found in Ozempic and Wegovy, but in a groundbreaking oral formulation. Understanding who makes Rybelsus provides insight into the rigorous development, quality standards, and clinical research behind this treatment option. Novo Nordisk's proprietary absorption technology enables semaglutide to be taken as a tablet rather than an injection, offering patients an alternative approach to managing their blood glucose levels alongside diet and exercise.
Quick Answer: Rybelsus is manufactured by Novo Nordisk, a Danish pharmaceutical company specialising in diabetes care.
Rybelsus is manufactured by Novo Nordisk, a Danish multinational pharmaceutical company with extensive experience in diabetes care. Novo Nordisk is a major producer of insulin and has developed numerous treatments for type 2 diabetes and obesity. The company's headquarters are located in Bagsværd, Denmark, with operations spanning more than 80 countries worldwide.
The development of Rybelsus represents an important advancement in diabetes treatment. Novo Nordisk created the first oral formulation of a glucagon-like peptide-1 (GLP-1) receptor agonist. Previously, all GLP-1 medications required injection, which presented barriers for some patients. The active ingredient in Rybelsus is semaglutide, the same molecule used in Novo Nordisk's injectable products Ozempic (for type 2 diabetes) and Wegovy (for weight management).
The innovation behind Rybelsus lies in its unique formulation technology. Novo Nordisk developed a proprietary absorption enhancer called SNAC (sodium N-(8-[2-hydroxybenzoyl] amino) caprylate), which protects semaglutide from degradation in the stomach and facilitates its absorption through the gastric mucosa. SNAC works by transiently increasing local gastric pH and enhancing transcellular absorption in the stomach. This technological advancement took years of research and clinical trials to develop, ultimately resulting in the first oral GLP-1 receptor agonist approved for clinical use.
Novo Nordisk continues to support ongoing research into semaglutide's applications, including cardiovascular outcomes studies and investigations into its broader metabolic effects. The company maintains quality control standards across its manufacturing facilities to ensure product consistency and patient safety.
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Rybelsus (oral semaglutide) is a prescription medication used to improve blood glucose control in adults with type 2 diabetes mellitus. It belongs to the GLP-1 receptor agonist class of antidiabetic medications and is typically used alongside diet and exercise modifications. Rybelsus is available in three tablet strengths: 3 mg, 7 mg, and 14 mg.
Importantly, the 3 mg dose is for initiation only and not for glycaemic control. Treatment starts with 3 mg once daily for 30 days, then increases to 7 mg once daily. After at least 30 days on the 7 mg dose, it may be increased to 14 mg once daily if additional glycaemic control is needed.
Mechanism of Action
Semaglutide works by mimicking the action of glucagon-like peptide-1 (GLP-1), a naturally occurring incretin hormone that plays a crucial role in glucose regulation. When you eat, GLP-1 is released from intestinal cells and performs several important functions:
Stimulates insulin secretion from pancreatic beta cells in a glucose-dependent manner, meaning it only triggers insulin release when blood glucose levels are elevated
Suppresses glucagon secretion from pancreatic alpha cells, reducing the liver's glucose production
Slows gastric emptying, which helps moderate the rise in blood glucose after meals
Reduces appetite through effects on brain centres that regulate food intake
The glucose-dependent mechanism of insulin secretion means that Rybelsus carries a lower risk of hypoglycaemia (dangerously low blood sugar) compared to some other diabetes medications, particularly when used as monotherapy or with metformin. However, the risk increases when combined with insulin or sulfonylureas.
Administration Requirements
Rybelsus requires specific administration instructions to ensure adequate absorption:
Take once daily on waking
Take on an empty stomach with no more than 120 mL of water
Swallow the tablet whole (do not split, crush or chew)
Wait at least 30 minutes before eating, drinking, or taking other oral medications
If a dose is missed, skip that dose and take the next scheduled dose the following day. Do not take a double dose to make up for a missed dose.
It's important to note that Rybelsus is not indicated for type 1 diabetes or diabetic ketoacidosis and is not a substitute for insulin. In line with NICE guidance, GLP-1 receptor agonists should not be combined with DPP-4 inhibitors.
Patients should be aware that levothyroxine exposure may increase when taken with Rybelsus; thyroid function monitoring may be needed when co-administered.
Rybelsus received marketing authorisation from the European Medicines Agency (EMA) in April 2020 and was subsequently approved by the Medicines and Healthcare products Regulatory Authority (MHRA) for use in the United Kingdom. The approval was based on the comprehensive PIONEER clinical trial programme, which evaluated oral semaglutide's efficacy and safety across diverse patient populations.
Key Clinical Trial Findings
The PIONEER programme comprised 10 phase 3 trials involving more than 9,500 adults with type 2 diabetes. Notable findings include:
PIONEER 1: Demonstrated significant HbA1c reductions of 0.9–1.4% with Rybelsus 7 mg and 14 mg compared to placebo over 26 weeks
PIONEER 4: Showed Rybelsus 14 mg was non-inferior to injectable liraglutide (another GLP-1 agonist) in reducing HbA1c
PIONEER 7: Found flexible dose adjustments of Rybelsus were effective in achieving glycaemic targets
Weight reduction: Across trials, patients experienced clinically meaningful weight loss of 2–4 kg on average
Cardiovascular Safety
The PIONEER 6 cardiovascular outcomes trial demonstrated that Rybelsus did not increase cardiovascular risk compared to placebo in patients with established cardiovascular disease or chronic kidney disease. This trial showed non-inferiority (safety) but was not powered to demonstrate cardiovascular benefit, unlike the SUSTAIN-6 trial with injectable semaglutide. The results confirmed cardiovascular safety—a critical regulatory requirement.
NICE Guidance
The National Institute for Health and Care Excellence (NICE) has incorporated GLP-1 receptor agonists, including Rybelsus, into its type 2 diabetes treatment pathway (NG28). NICE recommends considering GLP-1 agonists for patients who:
Have not achieved adequate glycaemic control with metformin and other oral therapies
Have a BMI of 35 kg/m² or higher (adjusted for ethnicity) and specific psychological or medical problems associated with obesity, or
Have a BMI lower than 35 kg/m² and insulin would have significant occupational implications or weight loss would benefit other significant obesity-related comorbidities
Importantly, NICE advises that GLP-1 receptor agonists should only be continued if the person has a beneficial metabolic response (a reduction of at least 11 mmol/mol [1.0%] in HbA1c and weight loss of at least 3% of initial body weight after 6 months). GLP-1 receptor agonists should not be combined with DPP-4 inhibitors. The choice between oral and injectable formulations should be made through shared decision-making, considering patient preferences and clinical circumstances.
Rybelsus is available on NHS prescription in the UK, though access may vary depending on local integrated care board (ICB) formularies and prescribing guidelines. As a relatively newer medication compared to established diabetes treatments, Rybelsus represents a higher cost option, which influences prescribing decisions within the NHS's resource-constrained environment.
NHS Prescribing Criteria
Access to Rybelsus on the NHS typically requires meeting specific clinical criteria:
Confirmed diagnosis of type 2 diabetes with inadequate glycaemic control (usually HbA1c ≥58 mmol/mol or 7.5%) despite lifestyle modifications and other oral antidiabetic medications
Body mass index (BMI) considerations, as outlined in NICE guidance (typically BMI ≥35 kg/m², adjusted for ethnicity, or lower if specific criteria are met)
Continuation only if there is a beneficial metabolic response (reduction of at least 11 mmol/mol [1.0%] in HbA1c and weight loss of at least 3% of initial body weight after 6 months)
Patient preference for oral rather than injectable therapy, where clinically appropriate
Local formulary policies may vary across regions. Patients should discuss eligibility with their GP or diabetes specialist team to understand local prescribing criteria.
NHS Cost Information
According to the British National Formulary (BNF), the NHS list price for Rybelsus (as of 2023) is approximately £78.20 for a 30-day supply, regardless of dose strength. Actual costs to the NHS may differ due to confidential pricing agreements. For private prescriptions, pharmacy dispensing fees and consultation costs may apply in addition to the medication cost.
Prescription Monitoring
Regardless of how Rybelsus is obtained, patients require regular monitoring including:
HbA1c measurements every 3–6 months to assess glycaemic control
Renal function tests, particularly if significant gastrointestinal adverse effects or dehydration occur (no dose adjustment is required for renal impairment)
Review of gastrointestinal side effects and tolerability
Assessment of weight changes and cardiovascular risk factors
Monitoring for diabetic retinopathy, particularly in patients with pre-existing retinopathy
Thyroid function tests if also taking levothyroxine, as semaglutide may increase levothyroxine exposure
When to Contact Your Healthcare Provider
Patients should seek medical advice if they experience:
Persistent or severe nausea or vomiting
Severe abdominal pain (which could indicate pancreatitis or gallbladder disease)
Signs of hypoglycaemia when combined with other diabetes medications
Visual changes or worsening of diabetic retinopathy
Signs of dehydration
Concerns about treatment effectiveness
Women of childbearing potential should use effective contraception when taking Rybelsus and stop treatment at least 2 months before a planned pregnancy.
Suspected adverse reactions should be reported via the MHRA Yellow Card scheme (yellowcard.mhra.gov.uk or the Yellow Card app).
Rybelsus is manufactured by Novo Nordisk, a Danish multinational pharmaceutical company headquartered in Bagsværd, Denmark, with operations in more than 80 countries worldwide. Novo Nordisk has extensive experience in diabetes care and developed the proprietary technology that enables oral semaglutide absorption.
Yes, Rybelsus is available on NHS prescription in the UK, though access depends on meeting specific clinical criteria outlined in NICE guidance and local integrated care board formularies. Patients typically need inadequate glycaemic control despite other treatments and must meet BMI criteria to be eligible.
Rybelsus is the first oral GLP-1 receptor agonist, whereas other GLP-1 medications require injection. Novo Nordisk developed SNAC absorption technology that protects semaglutide from stomach degradation and facilitates absorption through the gastric mucosa, enabling tablet formulation.
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DisclaimerThis content is not a substitute for professional medical advice, diagnosis, or treatment. Always consult a qualified healthcare professional with any medical questions or concerns. Use of the information is at your own risk, and we are not responsible for any consequences resulting from its use.
